Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:21 AM
Ignite Modification Date: 2025-12-25 @ 11:30 PM
NCT ID: NCT01227993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01227993
Study Brief: Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Finasteride Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits. None None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MeDRA 15.0 View
Aspartate aminotrasferase increased SYSTEMATIC_ASSESSMENT Investigations MeDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 15.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 15.0 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 15.0 View